Trial Outcomes & Findings for An Efficacy And Safety Study Evaluating Tofacitinib With And Without Methotrexate Compared To Adalimumab With Methotrexate (NCT NCT02187055)

Last Updated: 2018-06-27

Results Overview

ACR50 is a greater than or equal to (≥) 50 percent (%) improvement in tender joint count (TJC) or swollen joint count (SJC) and 50% improvement in 3 of the following 5 criteria: 1) physician's global assessment (PGA) of disease activity, 2) participant's assessment (PtGA) of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein (CRP) at each visit.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

1152 participants

Primary outcome timeframe

Month 6

Results posted on

2018-06-27

Participant Flow

Although a total of 1,152 participants were randomized, only 1,146 participants received treatment and are included in the full analysis set summarized below.

Participant milestones

Participant milestones
Measure	Tofacitinib 5 mg BID One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.	Tofacitinib 5 mg BID + MTX One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.	Adalimumab 40 mg + MTX One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.
Overall Study STARTED	384	376	386
Overall Study COMPLETED	315	303	312
Overall Study NOT COMPLETED	69	73	74

Reasons for withdrawal

Reasons for withdrawal
Measure	Tofacitinib 5 mg BID One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.	Tofacitinib 5 mg BID + MTX One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.	Adalimumab 40 mg + MTX One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.
Overall Study Lack of Efficacy	10	3	7
Overall Study Lost to Follow-up	2	7	3
Overall Study No longer meets eligibility criteria	0	2	0
Overall Study No longer willing to participate	6	8	10
Overall Study Other	5	6	3
Overall Study Protocol Violation	9	9	4
Overall Study Pregnancy	3	1	0
Overall Study Withdrawal by Subject	11	11	11
Overall Study Adverse Event	21	26	36
Overall Study Death	2	0	0

Baseline Characteristics

An Efficacy And Safety Study Evaluating Tofacitinib With And Without Methotrexate Compared To Adalimumab With Methotrexate

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tofacitinib 5 mg BID n=384 Participants One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.	Tofacitinib 5 mg BID + MTX n=376 Participants One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.	Adalimumab 40 mg + MTX n=386 Participants One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.	Total n=1146 Participants Total of all reporting groups
Age, Continuous	49.7 Years STANDARD_DEVIATION 12.2 • n=5 Participants	50.0 Years STANDARD_DEVIATION 13.4 • n=7 Participants	50.7 Years STANDARD_DEVIATION 13.4 • n=5 Participants	50.1 Years STANDARD_DEVIATION 13.0 • n=4 Participants
Sex: Female, Male Female	319 Participants n=5 Participants	311 Participants n=7 Participants	320 Participants n=5 Participants	950 Participants n=4 Participants
Sex: Female, Male Male	65 Participants n=5 Participants	65 Participants n=7 Participants	66 Participants n=5 Participants	196 Participants n=4 Participants

PRIMARY outcome

Timeframe: Month 6

Population: Full analysis set (FAS) included all participants who were randomized and received at least one dose of the randomized investigational drug (tofacitinib or adalimumab).

Outcome measures

Outcome measures
Measure	Tofacitinib 5 mg BID n=384 Participants One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.	Tofacitinib 5 mg BID + MTX n=376 Participants One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.	Adalimumab 40 mg + MTX n=386 Participants One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.
Percentage of Participants Achieving American College of Rheumatology Criteria 50% Improvement (ACR50) Response at Month 6	38.28 Percentage of participants	46.01 Percentage of participants	43.78 Percentage of participants

SECONDARY outcome

Timeframe: Month 6

Population: FAS

SDAI is the numerical sum of five outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PGA both assessed on a 0 to 10 centimeter (cm) visual analogue scale (VAS) (higher scores indicate greater affection due to disease activity), and CRP (mg/dL). SDAI total score ranges from 0 to 86. SDAI less than or equal to (≤) 3.3 indicates disease remission, \>3.4 to 11 indicates low disease activity, \>11 to 26 indicates moderate disease activity, and \>26 indicates high disease activity.

Outcome measures

Outcome measures
Measure	Tofacitinib 5 mg BID n=355 Participants One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.	Tofacitinib 5 mg BID + MTX n=343 Participants One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.	Adalimumab 40 mg + MTX n=345 Participants One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.
Change From Baseline in Simplified Disease Activity Index (SDAI) Value at Month 6	-23.7 Score on a scale Standard Error 0.62	-26.6 Score on a scale Standard Error 0.62	-25.6 Score on a scale Standard Error 0.62

SECONDARY outcome

Timeframe: Month 6

Population: FAS

CDAI is the numerical sum of four outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PGA both assessed on a 0 to 10 cm VAS (higher scores indicate greater affection due to disease activity). CDAI total score ranges from 0 to 76. CDAI ≤2.8 indicates disease remission, \>2.8 to 10 indicates low disease activity, \>10 to 22 indicates moderate disease activity, and \>22 indicates high disease activity.

Outcome measures

Outcome measures
Measure	Tofacitinib 5 mg BID n=357 Participants One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.	Tofacitinib 5 mg BID + MTX n=345 Participants One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.	Adalimumab 40 mg + MTX n=347 Participants One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.
Change From Baseline in Clinical Disease Activity Index (CDAI) Value at Month 6	-22.9 Score on a scale Standard Error 0.61	-25.5 Score on a scale Standard Error 0.61	-24.8 Score on a scale Standard Error 0.61

SECONDARY outcome

Timeframe: Month 6

Population: FAS

DAS28-4 (CRP) was calculated from the SJC and TJC (both based on a 28-joint assessment), PtGA (assessed on a 0 to 10 cm VAS; higher scores indicate greater affection due to disease activity) and CRP (mg/L) using the following: DAS28-4(CRP) = 0.56\*sqrt(TJC28) + 0.28\*sqrt(SJC28) + 0.36\*ln(CRP+1) + 0.014\* PtGA (millimeters \[mm\]) + 0.96. Total score range: 0 to 9.4, higher score indicated higher disease activity. DAS28-4 (CRP) ≤3.2 indicates low disease activity, \>3.2 to 5.1 indicates moderate to high disease activity, and less than (\<) 2.6 indicates remission.

Outcome measures

Outcome measures
Measure	Tofacitinib 5 mg BID n=355 Participants One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.	Tofacitinib 5 mg BID + MTX n=343 Participants One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.	Adalimumab 40 mg + MTX n=345 Participants One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.
Change From Baseline in Disease Activity Score 28-4 (DAS28-4) Including CRP at Month 6	-2.1 Score on a scale Standard Error 0.07	-2.5 Score on a scale Standard Error 0.07	-2.3 Score on a scale Standard Error 0.07

SECONDARY outcome

Timeframe: Month 6

Population: FAS

DAS28-4 (ESR) was calculated from the SJC and TJC (both based on a 28-joint assessment), PtGA (assessed on a 0 to 10 cm VAS; higher scores indicate greater affection due to disease activity) and ESR (mm/hour) using the following: DAS28-4(ESR) = 0.56\*sqrt(TJC28) + 0.28\*sqrt(SJC28) + 0.70\*ln(ESR) + 0.014\* PtGA (mm). Total score range: 0 to 9.4, higher score indicated higher disease activity. DAS28-3 (ESR) ≤3.2 indicates low disease activity, \>3.2 to 5.1 indicates moderate to high disease activity, and \<2.6 indicates remission.

Outcome measures

Outcome measures
Measure	Tofacitinib 5 mg BID n=349 Participants One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.	Tofacitinib 5 mg BID + MTX n=342 Participants One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.	Adalimumab 40 mg + MTX n=343 Participants One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.
Change From Baseline in Disease Activity Score 28-4 (DAS28-4) Including Erythrocyte Sedimentation Rate (ESR) at Month 6	-2.1 Score on a scale Standard Error 0.07	-2.4 Score on a scale Standard Error 0.07	-2.4 Score on a scale Standard Error 0.07

SECONDARY outcome

Timeframe: Month 6

Population: FAS

To meet the ACR-EULAR Boolean remission criteria, a participant must satisfy all of the following: TJC ≤1 and SJC ≤1 (both based on a 28-joint assessment), CRP ≤1 mg/dL, and PtGA ≤1 on a 0 to 10 cm VAS (higher scores indicate greater affection due to disease activity).

Outcome measures

Outcome measures
Measure	Tofacitinib 5 mg BID n=358 Participants One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.	Tofacitinib 5 mg BID + MTX n=346 Participants One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.	Adalimumab 40 mg + MTX n=355 Participants One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.
Percentage of Participants Achieving Observed American College of Rheumatology-European League Against Rheumatism (ACR-EULAR) Boolean Remission Criteria at Month 6	7.54 Percentage of participants	8.67 Percentage of participants	9.58 Percentage of participants

SECONDARY outcome

Timeframe: Month 6

Population: FAS

SDAI is the numerical sum of five outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PGA both assessed on a 0 to 10 cm VAS (higher scores indicate greater affection due to disease activity), and CRP (mg/dL). SDAI total score ranges from 0 to 86. SDAI ≤3.3 indicates disease remission.

Outcome measures

Outcome measures
Measure	Tofacitinib 5 mg BID n=357 Participants One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.	Tofacitinib 5 mg BID + MTX n=345 Participants One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.	Adalimumab 40 mg + MTX n=348 Participants One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.
Percentage of Participants Achieving SDAI ≤3.3 at Month 6	10.64 Percentage of participants 0.62	13.91 Percentage of participants 0.62	14.37 Percentage of participants 0.62

SECONDARY outcome

Timeframe: Month 6

Population: FAS

Outcome measures

Outcome measures
Measure	Tofacitinib 5 mg BID n=358 Participants One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.	Tofacitinib 5 mg BID + MTX n=347 Participants One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.	Adalimumab 40 mg + MTX n=350 Participants One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.
Percentage of Participants Achieving CDAI ≤2.8 at Month 6	10.89 Percentage of participants	14.70 Percentage of participants	14.57 Percentage of participants

SECONDARY outcome

Timeframe: Month 6

Population: FAS

DAS28-4 (ESR) was calculated from the SJC and TJC (both based on a 28-joint assessment), PtGA (assessed on a 0 to 10 cm VAS; higher scores indicate greater affection due to disease activity) and ESR (mm/hour) using the following: DAS28-4(ESR) = 0.56\*sqrt(TJC28) + 0.28\*sqrt(SJC28) + 0.70\*ln(ESR) + 0.014\* PtGA (mm). Total score range: 0 to 9.4, higher score indicates higher disease activity. DAS28-4 (ESR) \<2.6 indicates disease remission.

Outcome measures

Outcome measures
Measure	Tofacitinib 5 mg BID n=353 Participants One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.	Tofacitinib 5 mg BID + MTX n=344 Participants One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.	Adalimumab 40 mg + MTX n=346 Participants One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.
Percentage of Participants Achieving DAS28-4 (ESR) <2.6 at Month 6	11.33 Percentage of participants	12.79 Percentage of participants	13.58 Percentage of participants

SECONDARY outcome

Timeframe: Month 6

Population: FAS

DAS28-4 (CRP) was calculated from the SJC and TJC (both based on a 28-joint assessment), PtGA (assessed on a 0 to 10 cm VAS; higher scores indicate greater affection due to disease activity) and CRP (mg/L) using the following: DAS28-4(CRP) = 0.56\*sqrt(TJC28) + 0.28\*sqrt(SJC28) + 0.36\*ln(CRP+1) + 0.014\* PtGA (mm) + 0.96. Total score range: 0 to 9.4, higher score indicates higher disease activity. DAS28-4 (CRP) \<2.6 indicates remission.

Outcome measures

Outcome measures
Measure	Tofacitinib 5 mg BID n=357 Participants One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.	Tofacitinib 5 mg BID + MTX n=345 Participants One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.	Adalimumab 40 mg + MTX n=348 Participants One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.
Percentage of Participants Achieving DAS28-4 (CRP) <2.6 at Month 6	22.69 Percentage of participants	32.75 Percentage of participants	30.17 Percentage of participants

SECONDARY outcome

Timeframe: Month 6

Population: FAS

Outcome measures

Outcome measures
Measure	Tofacitinib 5 mg BID n=357 Participants One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.	Tofacitinib 5 mg BID + MTX n=345 Participants One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.	Adalimumab 40 mg + MTX n=348 Participants One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.
Percentage of Participants Achieving SDAI ≤11 at Month 6	46.78 Percentage of participants 0.62	53.33 Percentage of participants 0.62	51.15 Percentage of participants 0.62

SECONDARY outcome

Timeframe: Month 6

Population: FAS

Outcome measures

Outcome measures
Measure	Tofacitinib 5 mg BID n=358 Participants One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.	Tofacitinib 5 mg BID + MTX n=347 Participants One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.	Adalimumab 40 mg + MTX n=350 Participants One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.
Percentage of Participants Achieving CDAI ≤10 at Month 6	45.53 Percentage of participants	52.45 Percentage of participants	50.00 Percentage of participants

SECONDARY outcome

Timeframe: Month 6

Population: FAS

DAS28-4 (ESR) was calculated from the SJC and TJC (both based on a 28-joint assessment), PtGA (assessed on a 0 to 10 cm VAS; higher scores indicate greater affection due to disease activity) and ESR (mm/hour) using the following: DAS28-4(ESR) = 0.56\*sqrt(TJC28) + 0.28\*sqrt(SJC28) + 0.70\*ln(ESR) + 0.014\* PtGA (mm). Total score range: 0 to 9.4, higher score indicates higher disease activity. DAS28-4 (ESR) ≤3.2 indicates low disease activity.

Outcome measures

Outcome measures
Measure	Tofacitinib 5 mg BID n=353 Participants One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.	Tofacitinib 5 mg BID + MTX n=344 Participants One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.	Adalimumab 40 mg + MTX n=346 Participants One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.
Percentage of Participants Achieving DAS28-4 (ESR) ≤3.2 at Month 6	22.10 Percentage of participants	28.49 Percentage of participants	29.77 Percentage of participants

SECONDARY outcome

Timeframe: Month 6

Population: FAS

DAS28-4 (CRP) was calculated from the SJC and TJC (both based on a 28-joint assessment), PtGA (assessed on a 0 to 10 cm VAS; higher scores indicate greater affection due to disease activity) and CRP (mg/L) using the following: DAS28-4(CRP) = 0.56\*sqrt(TJC28) + 0.28\*sqrt(SJC28) + 0.36\*ln(CRP+1) + 0.014\* PtGA + 0.96. Total score range: 0 to 9.4, higher score indicated higher disease activity. DAS28-4 (CRP) ≤3.2 indicates low disease activity.

Outcome measures

Outcome measures
Measure	Tofacitinib 5 mg BID n=357 Participants One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.	Tofacitinib 5 mg BID + MTX n=345 Participants One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.	Adalimumab 40 mg + MTX n=348 Participants One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.
Percentage of Participants Achieving DAS28-4 (CRP) ≤3.2 at Month 6	44.54 Percentage of participants	49.57 Percentage of participants	50.86 Percentage of participants

SECONDARY outcome

Timeframe: Month 6

Population: FAS

ACR20 response is a ≥20% improvement in TJC or SJC and 20% improvement in 3 of the following 5 criteria: 1) PGA of disease activity, 2) PtGA of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) CRP at each visit.

Outcome measures

Outcome measures
Measure	Tofacitinib 5 mg BID n=354 Participants One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.	Tofacitinib 5 mg BID + MTX n=345 Participants One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.	Adalimumab 40 mg + MTX n=349 Participants One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.
Percentage of Participants Achieving American College of Rheumatology Criteria 20% Improvement (ACR20) Response at Month 6	70.06 Percentage of participants	79.13 Percentage of participants	77.65 Percentage of participants

SECONDARY outcome

Timeframe: Month 6

Population: FAS

ACR70 response is a ≥70% improvement in TJC or SJC and 70% improvement in 3 of the following 5 criteria: 1) PGA of disease activity, 2) PtGA of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) CRP at each visit.

Outcome measures

Outcome measures
Measure	Tofacitinib 5 mg BID n=356 Participants One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.	Tofacitinib 5 mg BID + MTX n=343 Participants One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.	Adalimumab 40 mg + MTX n=349 Participants One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.
Percentage of Participants Achieving American College of Rheumatology Criteria 70% Improvement (ACR70) Response at Month 6	19.66 Percentage of participants	27.11 Percentage of participants	22.64 Percentage of participants

SECONDARY outcome

Timeframe: Month 6

Population: FAS

The HAQ-DI is a participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dressing and grooming, arising, eating, walking, reach, grip, hygiene and other activities over the past week. Each activity category consists of 2 to 3 items. Each item is scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Any activity requiring assistance from another individual or the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score ranges from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty.

Outcome measures

Outcome measures
Measure	Tofacitinib 5 mg BID n=356 Participants One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.	Tofacitinib 5 mg BID + MTX n=348 Participants One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.	Adalimumab 40 mg + MTX n=350 Participants One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Month 6	-0.52 Units on a scale Standard Error 0.031	-0.58 Units on a scale Standard Error 0.031	-0.54 Units on a scale Standard Error 0.031

SECONDARY outcome

Timeframe: Month 6

Population: FAS

Outcome measures

Outcome measures
Measure	Tofacitinib 5 mg BID n=356 Participants One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.	Tofacitinib 5 mg BID + MTX n=348 Participants One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.	Adalimumab 40 mg + MTX n=350 Participants One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.
Percentage of Participants Achieving an HAQ-DI Decrease of at Least 0.22 at Month 6	71.07 Percentage of participants	75.57 Percentage of participants	72.86 Percentage of participants

SECONDARY outcome

Timeframe: Month 6

Population: FAS

The SF-36 health survey is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The health domains are aggregated into two summary scores known as the physical component summary (PCS) score and the mental component summary (MCS) score. Normalized domain scores, PCS and MCS scores are used in the analyses. The component and domain scores were scored using the United States (US) 1998 general population norms. The resulting norm-based scores for both the SF-36 version 2 (v2) and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher PCS score represents better physical health status.

Outcome measures

Outcome measures
Measure	Tofacitinib 5 mg BID n=355 Participants One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.	Tofacitinib 5 mg BID + MTX n=346 Participants One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.	Adalimumab 40 mg + MTX n=349 Participants One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.
Change From Baseline in the Short-Form-36 (SF-36) Health Survey, Physical Component Score at Month 6	6.7 Score on a scale Standard Error 0.44	7.9 Score on a scale Standard Error 0.43	7.8 Score on a scale Standard Error 0.43

SECONDARY outcome

Timeframe: Month 6

Population: FAS

The SF-36 health survey is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The health domains are aggregated into two summary scores known as the PCS score and the MCS score. Normalized domain scores, PCS and MCS scores are used in the analyses. The component and domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher MCS score represents better physical health status.

Outcome measures

Outcome measures
Measure	Tofacitinib 5 mg BID n=355 Participants One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.	Tofacitinib 5 mg BID + MTX n=346 Participants One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.	Adalimumab 40 mg + MTX n=349 Participants One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.
Change From Baseline in the SF-36 Health Survey, Mental Component Score at Month 6	5.2 Score on a scale Standard Error 0.52	5.7 Score on a scale Standard Error 0.51	4.4 Score on a scale Standard Error 0.51

SECONDARY outcome

Timeframe: Month 6

Population: FAS

SF-36v2 acute is a 36-item measure evaluating 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 10 items of the physical functioning scale represent levels and kinds of limitations between extremes of physical activities, including lifting and carrying groceries; climbing stairs; bending, kneeling, or stooping; walking moderate distances; self-care limitations. The physical functioning items capture the presence and extent of physical limitations using a 3-level response continuum. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher physical functioning domain score represents better physical functioning.

Outcome measures

Outcome measures
Measure	Tofacitinib 5 mg BID n=356 Participants One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.	Tofacitinib 5 mg BID + MTX n=348 Participants One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.	Adalimumab 40 mg + MTX n=349 Participants One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.
Change From Baseline in the SF-36 Health Survey, Physical Functioning Domain Score at Month 6	6.4 Score on a scale Standard Error 0.52	7.3 Score on a scale Standard Error 0.52	7.3 Score on a scale Standard Error 0.52

SECONDARY outcome

Timeframe: Month 6

Population: FAS

SF-36v2 acute is a 36-item measure evaluating 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 4-item role physical scale covers an array of physical health-related role limitations, including: a) limitations in the kind of work or other usual activities; b) reductions in the amount of time spent on work or other usual activities; c) difficulty performing work or other usual activities; and d) accomplishing less. Items in the role physical scale are answered on a 5-point scale. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher role physical domain score represents better role physical functioning.

Outcome measures

Outcome measures
Measure	Tofacitinib 5 mg BID n=356 Participants One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.	Tofacitinib 5 mg BID + MTX n=347 Participants One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.	Adalimumab 40 mg + MTX n=350 Participants One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.
Change From Baseline in the SF-36 Health Survey, Role Physical Domain Score at Month 6	6.7 Score on a scale Standard Error 0.47	7.0 Score on a scale Standard Error 0.47	6.3 Score on a scale Standard Error 0.47

SECONDARY outcome

Timeframe: Month 6

Population: FAS

The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The bodily pain scale comprises of 2 items pertaining to the intensity of bodily pain and extent of interference with normal work activities. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher bodily pain domain score represents less bodily pain.

Outcome measures

Outcome measures
Measure	Tofacitinib 5 mg BID n=356 Participants One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.	Tofacitinib 5 mg BID + MTX n=348 Participants One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.	Adalimumab 40 mg + MTX n=350 Participants One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.
Change From Baseline in the SF-36 Health Survey, Bodily Pain Domain Score at Month 6	8.2 Score on a scale Standard Error 0.48	10.3 Score on a scale Standard Error 0.48	9.9 Score on a scale Standard Error 0.48

SECONDARY outcome

Timeframe: Month 6

Population: FAS

The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The general health scale consists of 5 items including a rating of health and 4 items addressing the respondent's view and expectations of his or her health. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher general health domain score represents better general health perceptions.

Outcome measures

Outcome measures
Measure	Tofacitinib 5 mg BID n=357 Participants One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.	Tofacitinib 5 mg BID + MTX n=347 Participants One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.	Adalimumab 40 mg + MTX n=350 Participants One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.
Change From Baseline in the SF-36 Health Survey, General Health Domain Score at Month 6	5.1 Score on a scale Standard Error 0.44	6.3 Score on a scale Standard Error 0.44	5.4 Score on a scale Standard Error 0.44

SECONDARY outcome

Timeframe: Month 6

Population: FAS

The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 4-item measure of vitality captures a broad range of subjective evaluations of well-being from feelings of tiredness and being worn out to feeling full of energy all or most of the time. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher vitality domain score represents better vitality.

Outcome measures

Outcome measures
Measure	Tofacitinib 5 mg BID n=357 Participants One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.	Tofacitinib 5 mg BID + MTX n=348 Participants One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.	Adalimumab 40 mg + MTX n=350 Participants One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.
Change From Baseline in the SF-36 Health Survey, Vitality Domain Score at Month 6	5.6 Score on a scale Standard Error 0.48	6.1 Score on a scale Standard Error 0.47	5.7 Score on a scale Standard Error 0.47

SECONDARY outcome

Timeframe: Month 6

Population: FAS

The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 2-item social functioning scale assesses health-related effects on quantity and quality of social activities. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher social functioning domain score represents better social functioning.

Outcome measures

Outcome measures
Measure	Tofacitinib 5 mg BID n=357 Participants One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.	Tofacitinib 5 mg BID + MTX n=348 Participants One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.	Adalimumab 40 mg + MTX n=350 Participants One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.
Change From Baseline in the SF-36 Health Survey, Social Functioning Domain Score at Month 6	6.3 Score on a scale Standard Error 0.52	7.2 Score on a scale Standard Error 0.52	6.2 Score on a scale Standard Error 0.52

SECONDARY outcome

Timeframe: Month 6

Population: FAS

The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 3-item role emotional scale assesses mental health-related role limitations in terms of a) time spent in work or other usual activities; b) amount of work or activities accomplished; c) care with which work or other activities were performed. All 3 items are answered on a 5-point scale. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher role emotional domain score represents better role emotional functioning.

Outcome measures

Outcome measures
Measure	Tofacitinib 5 mg BID n=356 Participants One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.	Tofacitinib 5 mg BID + MTX n=347 Participants One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.	Adalimumab 40 mg + MTX n=350 Participants One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.
Change From Baseline in the SF-36 Health Survey, Role Emotional Domain Score at Month 6	6.7 Score on a scale Standard Error 0.58	7.7 Score on a scale Standard Error 0.58	6.0 Score on a scale Standard Error 0.58

SECONDARY outcome

Timeframe: Month 6

Population: FAS

The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 5-item mental health scale includes 1 or more items from each of 4 major mental health dimensions: anxiety, depression, loss of behavioral/emotional control, and psychological well-being. All items are answered on a 5-point scale. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher mental health domain score represents better mental health functioning.

Outcome measures

Outcome measures
Measure	Tofacitinib 5 mg BID n=356 Participants One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.	Tofacitinib 5 mg BID + MTX n=348 Participants One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.	Adalimumab 40 mg + MTX n=350 Participants One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.
Change From Baseline in the SF-36 Health Survey, Mental Health Domain Score at Month 6	5.3 Score on a scale Standard Error 0.52	5.5 Score on a scale Standard Error 0.52	5.0 Score on a scale Standard Error 0.52

SECONDARY outcome

Timeframe: Month 6

Population: FAS

The WPAI: Rheumatoid Arthritis is a 6 item questionnaire that is specific for rheumatoid arthritis and yields four types of scores: absenteeism, presenteesism (impairment at work/reduced job effectiveness), work productivity loss and activity impairment. WPAI outcomes are expressed as impairment percentages ranging from 0 to 100, with higher numbers indicating greater impairment and less productivity.

Outcome measures

Outcome measures
Measure	Tofacitinib 5 mg BID n=357 Participants One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.	Tofacitinib 5 mg BID + MTX n=341 Participants One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.	Adalimumab 40 mg + MTX n=343 Participants One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.
Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire at Month 6 Work hours missed due to problems	-2.62 Percentage of impairment Standard Error 0.717	-2.19 Percentage of impairment Standard Error 0.700	-1.75 Percentage of impairment Standard Error 0.741
Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire at Month 6 Work hours missed other reason	0.14 Percentage of impairment Standard Error 1.019	0.43 Percentage of impairment Standard Error 0.991	-0.77 Percentage of impairment Standard Error 1.059
Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire at Month 6 Hours worked in past 7 days	4.13 Percentage of impairment Standard Error 1.729	-0.82 Percentage of impairment Standard Error 1.672	1.28 Percentage of impairment Standard Error 1.788
Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire at Month 6 Problems affecting productivity	-1.94 Percentage of impairment Standard Error 0.228	-2.14 Percentage of impairment Standard Error 0.224	-1.95 Percentage of impairment Standard Error 0.232
Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire at Month 6 Problem affecting daily activities	-2.24 Percentage of impairment Standard Error 0.137	-2.47 Percentage of impairment Standard Error 0.138	-2.24 Percentage of impairment Standard Error 0.139
Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire at Month 6 % work time missed due to health	-4.51 Percentage of impairment Standard Error 1.790	-3.41 Percentage of impairment Standard Error 1.794	-1.87 Percentage of impairment Standard Error 1.831
Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire at Month 6 % impairment while working due to health	-19.38 Percentage of impairment Standard Error 2.276	-21.44 Percentage of impairment Standard Error 2.235	-19.52 Percentage of impairment Standard Error 2.320
Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire at Month 6 % overall work impairment due to health	-20.16 Percentage of impairment Standard Error 2.663	-22.27 Percentage of impairment Standard Error 2.638	-21.87 Percentage of impairment Standard Error 2.710
Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire at Month 6 % activity impairment due to health	-22.36 Percentage of impairment Standard Error 1.375	-24.74 Percentage of impairment Standard Error 1.383	-22.45 Percentage of impairment Standard Error 1.394

SECONDARY outcome

Timeframe: Month 6

Population: FAS

The EQ-5D is a participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). This profile of scores across the 5-dimensions (e.g. 11231, 33212, etc.) is transformed into a single health utility score using a formula developed by the EuroQol Group that applies country specific preference weights. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. The VAS component rated the current health state on a scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicating a better health state.

Outcome measures

Outcome measures
Measure	Tofacitinib 5 mg BID n=357 Participants One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.	Tofacitinib 5 mg BID + MTX n=348 Participants One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.	Adalimumab 40 mg + MTX n=351 Participants One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.
Change From Baseline in the EuroQol European Quality of Life-5 Dimensions (EuroQol EQ-5D) at Month 6 Utility score	0.20 Units on a scale Standard Error 0.013	0.22 Units on a scale Standard Error 0.013	0.22 Units on a scale Standard Error 0.013
Change From Baseline in the EuroQol European Quality of Life-5 Dimensions (EuroQol EQ-5D) at Month 6 Mobility score	-0.29 Units on a scale Standard Error 0.027	-0.26 Units on a scale Standard Error 0.027	-0.28 Units on a scale Standard Error 0.027
Change From Baseline in the EuroQol European Quality of Life-5 Dimensions (EuroQol EQ-5D) at Month 6 Self-care score	-0.27 Units on a scale Standard Error 0.028	-0.33 Units on a scale Standard Error 0.028	-0.32 Units on a scale Standard Error 0.028
Change From Baseline in the EuroQol European Quality of Life-5 Dimensions (EuroQol EQ-5D) at Month 6 Usual activities score	-0.24 Units on a scale Standard Error 0.029	-0.26 Units on a scale Standard Error 0.029	-0.30 Units on a scale Standard Error 0.029
Change From Baseline in the EuroQol European Quality of Life-5 Dimensions (EuroQol EQ-5D) at Month 6 Pain/discomfort score	-0.32 Units on a scale Standard Error 0.026	-0.34 Units on a scale Standard Error 0.026	-0.37 Units on a scale Standard Error 0.026
Change From Baseline in the EuroQol European Quality of Life-5 Dimensions (EuroQol EQ-5D) at Month 6 Anxiety/depression score	-0.21 Units on a scale Standard Error 0.029	-0.24 Units on a scale Standard Error 0.029	-0.22 Units on a scale Standard Error 0.029
Change From Baseline in the EuroQol European Quality of Life-5 Dimensions (EuroQol EQ-5D) at Month 6 VAS score	20.84 Units on a scale Standard Error 1.100	20.98 Units on a scale Standard Error 1.100	19.61 Units on a scale Standard Error 1.100

SECONDARY outcome

Timeframe: Month 6

Population: FAS

FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). The larger the participant's response (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score).

Outcome measures

Outcome measures
Measure	Tofacitinib 5 mg BID n=357 Participants One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.	Tofacitinib 5 mg BID + MTX n=348 Participants One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.	Adalimumab 40 mg + MTX n=352 Participants One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.
Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale Total Score at Month 6	7.14 Units on a scale Standard Error 0.500	7.59 Units on a scale Standard Error 0.498	6.07 Units on a scale Standard Error 0.499

Adverse Events

Tofacitinib 5 mg BID

Serious events: 35 serious events

Other events: 51 other events

Deaths: 0 deaths

Tofacitinib 5 mg BID + MTX

Serious events: 27 serious events

Other events: 72 other events

Deaths: 0 deaths

Adalimumab 40 mg + MTX

Serious events: 24 serious events

Other events: 69 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Tofacitinib 5 mg BID n=384 participants at risk One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.	Tofacitinib 5 mg BID + MTX n=376 participants at risk One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.	Adalimumab 40 mg + MTX n=386 participants at risk One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.
Infections and infestations Nasopharyngitis	5.7% 22/384 • SAEs were assessed from informed consent up to at least 28 calendar days after last dose of investigational product. AEs were recorded from the time the subject has taken at least one dose of study treatment through last subject visit. An event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event.	4.3% 16/376 • SAEs were assessed from informed consent up to at least 28 calendar days after last dose of investigational product. AEs were recorded from the time the subject has taken at least one dose of study treatment through last subject visit. An event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event.	4.7% 18/386 • SAEs were assessed from informed consent up to at least 28 calendar days after last dose of investigational product. AEs were recorded from the time the subject has taken at least one dose of study treatment through last subject visit. An event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event.
Infections and infestations Upper respiratory tract infection	6.5% 25/384 • SAEs were assessed from informed consent up to at least 28 calendar days after last dose of investigational product. AEs were recorded from the time the subject has taken at least one dose of study treatment through last subject visit. An event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event.	9.8% 37/376 • SAEs were assessed from informed consent up to at least 28 calendar days after last dose of investigational product. AEs were recorded from the time the subject has taken at least one dose of study treatment through last subject visit. An event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event.	7.5% 29/386 • SAEs were assessed from informed consent up to at least 28 calendar days after last dose of investigational product. AEs were recorded from the time the subject has taken at least one dose of study treatment through last subject visit. An event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event.
Investigations Alanine aminotransferase increased	2.1% 8/384 • SAEs were assessed from informed consent up to at least 28 calendar days after last dose of investigational product. AEs were recorded from the time the subject has taken at least one dose of study treatment through last subject visit. An event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event.	6.1% 23/376 • SAEs were assessed from informed consent up to at least 28 calendar days after last dose of investigational product. AEs were recorded from the time the subject has taken at least one dose of study treatment through last subject visit. An event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event.	6.7% 26/386 • SAEs were assessed from informed consent up to at least 28 calendar days after last dose of investigational product. AEs were recorded from the time the subject has taken at least one dose of study treatment through last subject visit. An event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event.

Additional Information

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Results disclosure agreements

Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the sponsor for review. Investigators will, on request, remove any previously undisclosed Confidential Information (other than the Study results themselves) before disclosure.
Publication restrictions are in place

Restriction type: OTHER